UTHealth | Clinical Trials

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test. - Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of <94% by pulse oximetry on room air or requiring supplemental oxygen. - Not anticipated to require mechanical ventilation within 48 hours.

Is taking high-dose hydroxychloroquine or chloroquine. - Is taking pimozide or strong or moderate CYP3A4 inhibitors. - Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis. - Has known hypersensitivity to any components of aprepitant injectable emulsion. - Has evidence of ARDS. - Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO. - Has multiple organ failure. - Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm	Description	Assigned Intervention
Experimental Treatment Group 1	Aprepitant injectable emulsion.	Drug: Aprepitant injectable emulsion Aprepitant injectable emulsion, once daily (QD) for 14 days.
Placebo Comparator Treatment Group 2	Saline placebo.	Drug: Saline Placebo Saline Placebo, once daily (QD) for 14 days.